Colombia issues a compulsory license on patents for the HIV drug Dolutegravir
Author: James Love
Request for CMS to provide a Bayh-Dole Section 202 license and a 28 USC 1498 authorization and consent to use three patents listed in the FDA Orange Book for the cancer drug enzalutamide
Letter from KEI, UACT and UAEM to Chiquita White Brooks-Lasure, Administrator of the Office of the Administrator, Centers for Medicare and Medicaid Services, at HHS, asking that CMS to provide a Bayh-Dole Section 202 license and a 28 USC 1498… Continue Reading
Brackets on March 23, 2024 INB text on Chapter 11
To get an idea of the challenges of getting agreement on the WHO pandemic accord text, consider the state of just one article on Saturday, March 23, 2024. Article 11 has 6 paragraphs on technology transfer. According to an analysis… Continue Reading
The March 7, 2024 WHO/INB draft negotiating text for a pandemic agreement.
The REVISED Draft of the negotiating text of the WHO Pandemic Agreement, March 7, 2024 INB_DRAFT_7March2024 A few quick word counts: mutually agreed 1 incentivize, 4 times Voluntary, 5 times take measures, 8 times Transparent or transparency, 8 cooperate 9… Continue Reading
KEI’s post hearing response to three questions regarding USTR’s Special 301 list
These are KEI’s post hearing responses to three questions regarding USTR’s Special 301 list. KEI-Special301-28Feb2024 One question was a follow up to KEI’s testimony that USTR should develop a policy on the trade related aspects of biomedical R&D that does… Continue Reading
Letter from Secretary Xavier Becerra rejecting appeal of the NIH rejection of the Xtandi petition, February 5, 2024
KEI’s comments to USTR on its 2024 Special 301 list
Prostate cancer patients ask Secretary Beccera to act on their appeal of rejection of the Xtandi march in and government use petititon
On December 19, 2023, three prostate cancer patients, Robert Sachs, Clare Love and Eric Sawyer, sent a letter to Secretary Becerra asking that he act on their appeal of the rejection of their petition, asking the federal government to use… Continue Reading
A quick FAQ on Bayh-Dole Act march-in rights
For journalists writing about march-in rights today, this is how it works. If you get money from the federal government for the R&D leading to an invention, there is typically a contract that gives the funder certain rights in any… Continue Reading
WHO Working Group on Amendments to the International Health Regulations
KEI statement to the Working Group on Amendments to the International Health Regulations December 7, 2023 KEI agrees with others that the IHR regulations should incorporate measures to address equitable access to products. KEI reminds delegations that in 2019, the… Continue Reading